This section provides downloadable licence application forms for medicines.
The application forms that appear on these pages cannot be used for electronic submissions through the MHRA Portal.
Companies registered on the Portal, should obtain application forms from the Portal eSubmission Workspace. Applications outside the remit of the Portal may be submitted using the relevant form on CD/DVD or paper. See application types acceptable via eSubmissions on the MHRA Portal.
If you have any problems downloading the forms, please use our technical feedback form.
Clinical trials
Please use the application forms on EudraCT on the European Medicines Agency (EMA) website (external link).
Marketing authorisation application forms
Manufacturer’s licence forms
This page contains all manufacturer's licence application forms, including variations. It covers applications for products for human use and veterinary use.
Import, export, and labelling and leaflet forms
Wholesale dealer's licences application forms
Summary of Product Characteristics templates and fragments
Go to the Summary of Product Characteristics templates and fragments
Other licence application forms
This page contains forms for drug device combinations, herbal and homeopathic products, non-orthodox practitioners and Periodic Safety Update Report submissions.
